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Coronary Artery Disease: HELP
Articles by Peter Juni
Based on 57 articles published since 2008
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Between 2008 and 2019, Peter Jüni wrote the following 57 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
1 Guideline 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS. 2018

Valgimigli, Marco / Bueno, Héctor / Byrne, Robert A / Collet, Jean-Philippe / Costa, Francesco / Jeppsson, Anders / Jüni, Peter / Kastrati, Adnan / Kolh, Philippe / Mauri, Laura / Montalescot, Gilles / Neumann, Franz-Josef / Petricevic, Mate / Roffi, Marco / Steg, Philippe Gabriel / Windecker, Stephan / Zamorano, Jose Luis / Levine, Glenn N / Anonymous3740973. · ·Eur J Cardiothorac Surg · Pubmed #29045581.

ABSTRACT: -- No abstract --

2 Guideline Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. 2018

Byrne, Robert A / Stefanini, Giulio G / Capodanno, Davide / Onuma, Yoshinobu / Baumbach, Andreas / Escaned, Javier / Haude, Michael / James, Stefan / Joner, Michael / Jüni, Peter / Kastrati, Adnan / Oktay, Semih / Wijns, William / Serruys, Patrick W / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Germany. ·EuroIntervention · Pubmed #28948934.

ABSTRACT: A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

3 Guideline [2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS.] 2017

Valgimigli, Marco / Bueno, Héctor / Byrne, Robert A / Collet, Jean-Philippe / Costa, Francesco / Jeppsson, Anders / Jüni, Peter / Kastrati, Adnan / Kolh, Philippe / Mauri, Laura / Montalescot, Gilles / Neumann, Franz-Josef / Peticevic, Mate / Roffi, Marco / Steg, Philippe Gabriel / Windecker, Stephan / Zamorano, Jose Luis. ·Cardiology, Inselspital, Bern. marco.valgimigli@insel.ch. ·Kardiol Pol · Pubmed #29251754.

ABSTRACT: -- No abstract --

4 Guideline Meeting report ESC forum on drug eluting stents, European Heart House, Nice, 27-28 September 2007. 2009

Daemen, Joost / Simoons, Maarten L / Wijns, William / Bagust, Adrian / Bos, Gert / Bowen, James M / Braunwald, Eugene / Camenzind, Edoardo / Chevaliers, Bernard / DiMario, Carlo / Fajadeto, Jean / Gitt, Anselm / Guagliumi, Giulio / Hillege, Hans L / James, Stefan / Jüni, Peter / Kastrati, Adnan / Kloth, Sabine / Kristensen, Steen D / Krucoff, Mitchell / Legrand, Victor / Pfisterer, Matthias / Rothman, Martin / Serruys, Patrick W / Silber, Sigmund / Steg, Philippe G / Tariah, Ibrahim / Wallentin, Lars / Windecker, Stephan W / Aimonetti, A / Allocco, D / Berenger, M / Boam, A / Calle, J P / Campo, G / Carlier, S / de Schepper, J / Di Bisceglie, G / Dobbels, H / Farb, A / Ghislain, J C / Hellbardt, S / ten Hoedt, R / Isaia, C / de Jong, P / Lekehal, M / LeNarz, L / Mhullain, F Ni / Nagai, H / Patteet, A / Paunovic, D / Potgieter, A / Purdy, I / Raveau-Landon, C / Ternstrom, S / Van Wuytswinkel, J / Waliszewski, M / Anonymous830624. ·Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #19284063.

ABSTRACT: -- No abstract --

5 Editorial The drug-eluting stent saga. 2009

Windecker, Stephan / Jüni, Peter. · ·Circulation · Pubmed #19204314.

ABSTRACT: -- No abstract --

6 Review Outcomes of non-invasive diagnostic modalities for the detection of coronary artery disease: network meta-analysis of diagnostic randomised controlled trials. 2018

Siontis, George Cm / Mavridis, Dimitris / Greenwood, John P / Coles, Bernadette / Nikolakopoulou, Adriani / Jüni, Peter / Salanti, Georgia / Windecker, Stephan. ·Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland. · Department of Primary Education, University of Ioannina, Ioannina, Greece. · Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK. · Cancer Research Wales Library, Velindre National Health Trust, Cardiff, UK. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada. · Department of Cardiology, Bern University Hospital, Inselspital, Bern, Switzerland stephan.windecker@insel.ch. ·BMJ · Pubmed #29467161.

ABSTRACT: OBJECTIVE: To evaluate differences in downstream testing, coronary revascularisation, and clinical outcomes following non-invasive diagnostic modalities used to detect coronary artery disease. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Medline, Medline in process, Embase, Cochrane Library for clinical trials, PubMed, Web of Science, SCOPUS, WHO International Clinical Trials Registry Platform, and Clinicaltrials.gov. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Diagnostic randomised controlled trials comparing non-invasive diagnostic modalities in patients presenting with symptoms suggestive of low risk acute coronary syndrome or stable coronary artery disease. DATA SYNTHESIS: A random effects network meta-analysis synthesised available evidence from trials evaluating the effect of non-invasive diagnostic modalities on downstream testing and patient oriented outcomes in patients with suspected coronary artery disease. Modalities included exercise electrocardiograms, stress echocardiography, single photon emission computed tomography-myocardial perfusion imaging, real time myocardial contrast echocardiography, coronary computed tomographic angiography, and cardiovascular magnetic resonance. Unpublished outcome data were obtained from 11 trials. RESULTS: 18 trials of patients with low risk acute coronary syndrome (n=11 329) and 12 trials of those with suspected stable coronary artery disease (n=22 062) were included. Among patients with low risk acute coronary syndrome, stress echocardiography, cardiovascular magnetic resonance, and exercise electrocardiograms resulted in fewer invasive referrals for coronary angiography than coronary computed tomographic angiography (odds ratio 0.28 (95% confidence interval 0.14 to 0.57), 0.32 (0.15 to 0.71), and 0.53 (0.28 to 1.00), respectively). There was no effect on the subsequent risk of myocardial infarction, but estimates were imprecise. Heterogeneity and inconsistency were low. In patients with suspected stable coronary artery disease, an initial diagnostic strategy of stress echocardiography or single photon emission computed tomography-myocardial perfusion imaging resulted in fewer downstream tests than coronary computed tomographic angiography (0.24 (0.08 to 0.74) and 0.57 (0.37 to 0.87), respectively). However, exercise electrocardiograms yielded the highest downstream testing rate. Estimates for death and myocardial infarction were imprecise without clear discrimination between strategies. CONCLUSIONS: For patients with low risk acute coronary syndrome, an initial diagnostic strategy of stress echocardiography or cardiovascular magnetic resonance is associated with fewer referrals for invasive coronary angiography and revascularisation procedures than non-invasive anatomical testing, without apparent impact on the future risk of myocardial infarction. For suspected stable coronary artery disease, there was no clear discrimination between diagnostic strategies regarding the subsequent need for invasive coronary angiography, and differences in the risk of myocardial infarction cannot be ruled out. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registry no CRD42016049442.

7 Review Impact of total arterial revascularization on long term survival: A systematic review and meta-analysis of 130,305 patients. 2017

Yanagawa, Bobby / Verma, Subodh / Mazine, Amine / Tam, Derrick Y / Jüni, Peter / Puskas, John D / Murugavel, Shamini / Friedrich, Jan O. ·Division of Cardiac Surgery, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Electronic address: yanagawab@smh.ca. · Division of Cardiac Surgery, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. · Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. · Department of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA. · Critical Care and Medicine Departments, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. ·Int J Cardiol · Pubmed #28185702.

ABSTRACT: OBJECTIVES: This meta-analysis compares total arterial revascularization (TAR) versus conventional coronary artery bypass and additionally to two arterial grafts. METHODS: We searched MEDLINE and EMBASE Databases from 1996-to-2016 for studies comparing TAR versus non-TAR for multi-vessel surgical revascularization. Data were extracted by 2 independent investigators. Meta-analysis used random effects, which incorporates heterogeneity. RESULTS: There were 4 smaller shorter follow-up randomized controlled trials (RCTs), plus 15 matched/adjusted and 6 unmatched/unadjusted larger longer follow-up observational studies that met inclusion criteria (N=130.305 patients; mean follow-up range: 1-15years). There were no differences in perioperative stroke, myocardial infarction or mortality. However, TAR was associated with lower long term all-cause mortality in observational studies matched/adjusted for confounders (incident rate ratio 0.85, 95% CI: 0.81-0.89, p<0.0001; I CONCLUSIONS: Data from primarily observational studies suggest that TAR may improve long-term survival compared with conventional coronary bypass by 15-20% even when compared with two arterial grafts. Prospective randomized trials of TAR with long term follow-up are needed.

8 Review Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary. 2015

Byrne, Robert A / Serruys, Patrick W / Baumbach, Andreas / Escaned, Javier / Fajadet, Jean / James, Stefan / Joner, Michael / Oktay, Semih / Jüni, Peter / Kastrati, Adnan / Sianos, George / Stefanini, Giulio G / Wijns, William / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. · Bristol Heart Institute, Bristol, UK. · Interventional Cardiology, Hospital San Carlos, Madrid, Spain. · Interventional Cardiology, Clinique Pasteur, Toulouse, France. · Clinical Research Center, Uppsala University, Uppsala, Sweden. · CVPath Institute, Inc., Gaithersburg, USA. · Cardio Med Device Consultants, Baltimore, USA. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · AHEPA University Hospital, Thessaloniki, Greece. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Cardiovascular Center O.L.V.Z., Aalst, Belgium. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·Eur Heart J · Pubmed #26071600.

ABSTRACT: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

9 Article Ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents versus thin-strut, durable-polymer, everolimus-eluting stents for percutaneous coronary revascularisation: 5-year outcomes of the BIOSCIENCE randomised trial. 2018

Pilgrim, Thomas / Piccolo, Raffaele / Heg, Dik / Roffi, Marco / Tüller, David / Muller, Olivier / Moarof, Igal / Siontis, George C M / Cook, Stéphane / Weilenmann, Daniel / Kaiser, Christoph / Cuculi, Florim / Hunziker, Lukas / Eberli, Franz R / Jüni, Peter / Windecker, Stephan. ·Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: thomas.pilgrim@insel.ch. · Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Naples, Italy. · Institute of Social and Preventive Medicine, Inselspital, University of Bern, Bern, Switzerland; Clinical Trials Unit, Inselspital, University of Bern, Bern, Switzerland. · Department of Cardiology, Geneva University Hospital, Geneva, Switzerland. · Department of Cardiology, Triemlispital, Zurich, Switzerland. · Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. · Department of Cardiology, Kantonsspital Aarau, Aarau, Switzerland. · Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. · Department of Cardiology, University and Hospital Fribourg, Fribourg, Switzerland. · Department of Cardiology, Kantonsspital St Gallen, St Gallen, Switzerland. · Department of Cardiology, University Hospital Basel, Basel, Switzerland. · Department of Cardiology, Luzerner Kantonsspital, Luzern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. ·Lancet · Pubmed #30170848.

ABSTRACT: BACKGROUND: Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. METHODS: In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. FINDINGS: 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88-1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06-1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51-2·05; p=0·950). INTERPRETATION: 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. FUNDING: Clinical Trials Unit of the University of Bern and Biotronik.

10 Article Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. 2018

Vranckx, Pascal / Valgimigli, Marco / Jüni, Peter / Hamm, Christian / Steg, Philippe Gabriel / Heg, Dik / van Es, Gerrit Anne / McFadden, Eugene P / Onuma, Yoshinobu / van Meijeren, Cokky / Chichareon, Ply / Benit, Edouard / Möllmann, Helge / Janssens, Luc / Ferrario, Maurizio / Moschovitis, Aris / Zurakowski, Aleksander / Dominici, Marcello / Van Geuns, Robert Jan / Huber, Kurt / Slagboom, Ton / Serruys, Patrick W / Windecker, Stephan / Anonymous2921283. ·Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Université Paris-Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, French Alliance for Cardiovascular Trials, Paris, France; National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · European Cardiovascular Research Institute, Rotterdam, Netherlands. · Cork University Hospital, Cork, Ireland. · Erasmus Medical Center, Rotterdam, Netherlands; Cardialysis, Rotterdam, Netherlands. · Cardialysis, Rotterdam, Netherlands. · Academic Medical Center of Amsterdam, Amsterdam, Netherlands. · Imeldaziekenhuis, Bonheiden, Belgium. · UOC Cardiologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. · American Heart of Poland, Center for Cardiovascular Research and Development, Katowice, Poland. · Azienda Ospedaliera S Maria, Terni, Italy. · Erasmus Medical Center, Rotterdam, Netherlands. · 3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminenhospital and Sigmund Freud University, Medical Faculty, Vienna, Austria. · Onze Lieve vrouwe Gasthuis, Amsterdam, Netherlands. · Erasmus Medical Center, Rotterdam, Netherlands; Academic Medical Center of Amsterdam, Amsterdam, Netherlands. Electronic address: patrick.w.j.c.serruys@gmail.com. · Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Lancet · Pubmed #30166073.

ABSTRACT: BACKGROUND: We hypothesised that ticagrelor, in combination with aspirin for 1 month, followed by ticagrelor alone, improves outcomes after percutaneous coronary intervention compared with standard antiplatelet regimens. METHODS: GLOBAL LEADERS was a randomised, open-label superiority trial at 130 sites in 18 countries. Patients undergoing percutaneous coronary intervention with a biolimus A9-eluting stent for stable coronary artery disease or acute coronary syndromes were randomly assigned (1:1) to 75-100 mg aspirin daily plus 90 mg ticagrelor twice daily for 1 month, followed by 23 months of ticagrelor monotherapy, or standard dual antiplatelet therapy with 75-100 mg aspirin daily plus either 75 mg clopidogrel daily (for patients with stable coronary artery disease) or 90 mg ticagrelor twice daily (for patients with acute coronary syndromes) for 12 months, followed by aspirin monotherapy for 12 months. Randomisation was concealed, stratified by centre and clinical presentation (stable coronary artery disease vs acute coronary syndrome), and blocked, with randomly varied block sizes of two and four. The primary endpoint at 2 years was a composite of all-cause mortality or non-fatal centrally adjudicated new Q-wave myocardial infarction as assessed by a core lab in a blinded manner. The key secondary safety endpoint was site-reported bleeding assessed according to the Bleeding Academic Research Consortium criteria (grade 3 or 5). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01813435, and is closed to new participants, with follow-up completed. FINDINGS: Between July 1, 2013, and Nov 9, 2015, 15 968 participants were randomly assigned, 7980 to the experimental group and 7988 to the control group. At 2 years, 304 (3·81%) participants in the experimental group had died or had a non-fatal centrally adjudicated new Q-wave myocardial infarction, compared with 349 (4·37%) participants in the control group (rate ratio 0·87 [95% CI 0·75-1·01]; p=0·073]). There was no evidence for a difference in treatment effects for the primary endpoint across prespecified subgroups of acute coronary syndromes and stable coronary artery disease (p=0·93). Grade 3 or 5 bleeding occurred in 163 participants in the experimental group and 169 in the control group (2·04% vs 2·12%; rate ratio 0·97 [95% CI 0·78-1·20]; p=0·77). INTERPRETATION: Ticagrelor in combination with aspirin for 1 month followed by ticagrelor alone for 23 months was not superior to 12 months of standard dual antiplatelet therapy followed by 12 months of aspirin alone in the prevention of all-cause mortality or new Q-wave myocardial infarction 2 years after percutaneous coronary intervention. FUNDING: AstraZeneca, Biosensors, and The Medicines Company.

11 Article Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). 2018

Fearon, William F / Nishi, Takeshi / De Bruyne, Bernard / Boothroyd, Derek B / Barbato, Emanuele / Tonino, Pim / Jüni, Peter / Pijls, Nico H J / Hlatky, Mark A / Anonymous831118. ·Division of Cardiovascular Medicine (W.F.F., T.N., M.A.H.) wfearon@stanford.edu. · Division of Cardiovascular Medicine (W.F.F., T.N., M.A.H.). · Stanford University School of Medicine and Stanford Cardiovascular Institute, CA. Cardiovascular Center Aalst, Belgium (B.D.B., E.B.). · Quantitative Sciences Unit (D.B.B.). · Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy (E.B.). · Catharina Hospital, Eindhoven, the Netherlands (P.T., N.H.J.P.). · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Ontario, Canada (P.J.). · Department of Health Research and Policy (M.A.H.). ·Circulation · Pubmed #29097450.

ABSTRACT: BACKGROUND: Previous studies found that percutaneous coronary intervention (PCI) does not improve outcome compared with medical therapy (MT) in patients with stable coronary artery disease, but PCI was guided by angiography alone. FAME 2 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) compared PCI guided by fractional flow reserve with best MT in patients with stable coronary artery disease to assess clinical outcomes and cost-effectiveness. METHODS: A total of 888 patients with stable single-vessel or multivessel coronary artery disease with reduced fractional flow reserve were randomly assigned to PCI plus MT (n=447) or MT alone (n=441). Major adverse cardiac events included death, myocardial infarction, and urgent revascularization. Costs were calculated on the basis of resource use and Medicare reimbursement rates. Changes in quality-adjusted life-years were assessed with utilities determined by the European Quality of Life-5 Dimensions health survey at baseline and over follow-up. RESULTS: Major adverse cardiac events at 3 years were significantly lower in the PCI group compared with the MT group (10.1% versus 22.0%; CONCLUSIONS: PCI of lesions with reduced fractional flow reserve improves long-term outcome and is economically attractive compared with MT alone in patients with stable coronary artery disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01132495.

12 Article Midterm clinical outcomes with everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for percutaneous coronary interventions: a meta-analysis of randomised trials. 2018

Cassese, Salvatore / Byrne, Robert A / Jüni, Peter / Wykrzykowska, Joanna J / Puricel, Serban / Ndrepepa, Gjin / Schunkert, Heribert / Fusaro, Massimiliano / Cook, Stephane / Kimura, Takeshi / Henriques, Jose P S / Serruys, Patrick W / Windecker, Stephan / Kastrati, Adnan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. ·EuroIntervention · Pubmed #28671552.

ABSTRACT: bioresorbable vascular scaffold (BVS) versus an everolimus-eluting metallic stent (EES) for percutaneous coronary interventions. METHODS AND RESULTS: We performed a meta-analysis of aggregate data by searching Medline, EMBASE, Cochrane databases and proceedings of international meetings for randomised trials reporting the clinical outcomes beyond one year of patients treated with BVS versus EES. The primary efficacy and safety outcomes were target lesion failure (TLF) and definite/probable stent (scaffold) thrombosis (ST), respectively. Secondary outcomes were the individual components of the primary efficacy outcome (cardiac death, target vessel myocardial infarction [MI], and ischaemia-driven target lesion revascularisation [ID-TLR]). A total of 5,583 patients randomly received BVS (n=3,261) or EES (n=2,322) in seven trials. Weighted median follow-up was 26.6 months. Patients treated with BVS versus EES showed a higher risk of TLF (odds ratio [OR] 1.35, 95% confidence interval [CI]: 1.11-1.65; p=0.0028) due to a higher risk of target vessel MI (OR 1.68, 95% CI: 1.21-2.33; p=0.008) and ID-TLR (OR 1.42, 95% CI: 1.10-1.84; p=0.007) though the risk for cardiac death was not statistically different (OR 0.89, 95% CI: 0.55-1.43; p=0.56). Patients treated with BVS versus EES showed a higher risk of definite/probable ST (OR 3.24, 95% CI: 1.92-5.49; p<0.0001), particularly in the period beyond one year after implantation (OR 4.03, 95% CI: 1.49-10.87; p=0.006). CONCLUSIONS: At midterm follow-up, patients treated with BVS as compared to those treated with EES display a higher risk of target lesion failure and scaffold thrombosis.

13 Article Cysteine-rich angiogenic inducer 61 (Cyr61): a novel soluble biomarker of acute myocardial injury improves risk stratification after acute coronary syndromes. 2017

Klingenberg, Roland / Aghlmandi, Soheila / Liebetrau, Christoph / Räber, Lorenz / Gencer, Baris / Nanchen, David / Carballo, David / Akhmedov, Alexander / Montecucco, Fabrizio / Zoller, Stefan / Brokopp, Chad / Heg, Dik / Jüni, Peter / Marti Soler, Helena / Marques-Vidal, Pedro-Manuel / Vollenweider, Peter / Dörr, Oliver / Rodondi, Nicolas / Mach, François / Windecker, Stephan / Landmesser, Ulf / von Eckardstein, Arnold / Hamm, Christian W / Matter, Christian M / Lüscher, Thomas F. ·Department of Cardiology, University Heart Center, University Hospital of Zurich and Center for Molecular Cardiology, University of Zurich, Rämistr. 100, CH-8091 Zurich, Switzerland and Wagistr. 12, CH-8952 Schlieren, Switzerland. · Department of Cardiology, Kerckhoff Heart and Thorax Center, Kerckhoff-Klinik, Benekestr. 2-8, D-61231 Bad Nauheim, Germany. · DZHK (German Center for Cardiovascular Research), Partner Site Rhine-Main, Benekestr. 2-8, D-61231 Bad Nauheim, Germany. · Institute of Social and Preventive Medicine (ISPM), University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland. · CTU Bern, University of Bern, Finkenhubelweg 11, CH-3012 Bern, Switzerland. · Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Spitalstr. 12, CH-4056 Basel, Switzerland. · Department of Cardiology, Cardiovascular Center, University Hospital of Bern, Freiburgstr. 18, CH-3010 Bern, Switzerland. · Department of Cardiology, Cardiovascular Center, University Hospital of Geneva, Rue Gabrielle-Perret-Gentil 4, CH-1211 Geneva 14, Switzerland. · Department of Ambulatory Care and Community Medicine, University of Lausanne, Rue du Bugnon 44, CH-1011 Lausanne, Switzerland. · First Clinic of Internal Medicine, Department of Internal Medicine, University of Genoa, 6, Viale Benedetto XV, IT-16132 Genoa, Italy. · Bioinformatics, Genetic Diversity Center, Federal Institute of Technology (ETH), Universitätsstr. 16, CH-8092 Zurich, Switzerland. · Department of Cardiothoracic Surgery, Regenerative Medicine Center, Department of Cardiothoracic Surgery, University Hospital of Zurich, Wagistr. 12, CH-8952 Schlieren, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, 209 Victoria St, Toronto, ON M5B 1T8, Canada. · Department of General Internal Medicine, University Hospital of Lausanne, Rue du Bugnon 46, CH-1011 Lausanne, Switzerland. · Department of Cardiology, University Hospital of Giessen, Klinikstr. 33; D-35392 Giessen, Germany. · Institute of Primary Health Care (BIHAM), University of Bern, Gesellschaftsstr. 49, CH-3012 Bern, Switzerland. · Department of General Internal Medicine, University Hospital of Bern, Freiburgstr. 18, CH-3010 Bern, Switzerland. · Department of Cardiology, Charité Campus Benjamin-Franklin, Hindenburgdamm 30, D-12200 Berlin, Germany. · Institute of Clinical Chemistry, University Hospital of Zurich, Rämistr. 100, CH-8091 Zurich, Switzerland. ·Eur Heart J · Pubmed #29155984.

ABSTRACT: Aims: We aimed to identify a novel biomarker involved in the early events leading to an acute coronary syndrome (ACS) and evaluate its role in diagnosis and risk stratification. Methods and results: Biomarker identification was based on gene expression profiling. In coronary thrombi of ACS patients, cysteine-rich angiogenic inducer 61 (Cyr61, CCN1) gene transcripts were highly up-regulated compared with peripheral mononuclear cells. In a murine ischaemia-reperfusion model (I/R), myocardial Cyr61 expression was markedly increased compared with the controls. Cyr61 levels were determined in human serum using an enzyme-linked immunosorbent assay. Cohorts of ACS (n = 2168) referred for coronary angiography, stable coronary artery disease (CAD) (n = 53), and hypertrophic obstructive cardiomyopathy (HOCM) patients (n = 15) served to identify and evaluate the diagnostic and prognostic performance of the biomarker. Cyr61 was markedly elevated in ST-elevation myocardial infarction patients compared with non-ST-elevation myocardial infarction/unstable angina or stable CAD patients, irrespective of whether coronary thrombi were present. Cyr61 was rapidly released after occlusion of a septal branch in HOCM patients undergoing transcoronary ablation of septal hypertrophy. Cyr61 improved risk stratification for all-cause mortality when added to the reference GRACE risk score at 30 days (C-statistic 0.88 to 0.89, P = 0.001) and 1 year (C-statistic 0.77 to 0.80, P < 0.001) comparable to high-sensitivity troponin T (30 days: 0.88 to 0.89, P < 0.001; 1 year: 0.77 to 0.79, P < 0.001). Similar results were obtained for the composite endpoint of all-cause mortality or myocardial infarction. Conversely, in a population-based case-control cohort (n = 362), Cyr61 was not associated with adverse outcome. Conclusion: Cyr61 is a novel early biomarker reflecting myocardial injury that improves risk stratification in ACS patients.

14 Article A randomized multicenter trial comparing the XIENCE everolimus eluting stent with the CYPHER sirolimus eluting stent in the treatment of female patients with de novo coronary artery lesions: The SPIRIT WOMEN study. 2017

Franzone, Anna / Zaugg, Serge / Piccolo, Raffaele / Modena, Maria Grazia / Mikhail, Ghada W / Ferré, Josepa Mauri / Strasser, Ruth / Grinfeld, Liliana / Heg, Dik / Jüni, Peter / Windecker, Stephan / Morice, Marie-Claude. ·Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland. · Institute of Cardiology, Policlinico Hospital, University of Modena and Reggio Emilia, Modena, Italy. · Imperial College Healthcare NHS Trust, London, United Kingdom. · Hospital Germans Trias I Pujol, Invasive Cardiology Unit, Badalona, Spain. · University of Dresden, Department of Internal Medicine and Cardiology, Heart Centre, University Hospital, Dresden, Germany. · Hospital Italiano, Invasive Cardiology Unit, Buenos Aires, Argentina. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. · Institut Cardiovasculaire Paris Sud, Paris, France. ·PLoS One · Pubmed #28796809.

ABSTRACT: BACKGROUND: The comparative performance of different drug-eluting stents (DES) among female patients has not been assessed in a randomized manner. OBJECTIVES: The SPIRIT Women Clinical Evaluation trial compared the durable polymer everolimus-eluting XIENCE stent (DP-EES) with the durable polymer sirolimus-eluting Cypher stent (DP-SES) in women undergoing percutaneous coronary intervention (PCI). METHODS: A total of 455 female patients with stable CAD were randomly assigned to receive DP-EES (n = 304) or DP-SES (n = 151). The powered angiographic outcome of the trial was in-stent late lumen loss (LLL) at 9 months after the index procedure. Secondary angiographic end points included in-segment LLL, in-stent and in-segment binary restenosis and percent diameter stenosis. The primary clinical outcome was a composite of all-cause death, myocardial infarction (MI) or target vessel revascularization (TVR). RESULTS: At 9-month follow-up, in-stent LLL was 0.19±0.38 mm and 0.11±0.37 mm in patients assigned to DP-EES and DP-SES, respectively. The one-sided upper 95% CI of the difference in in-stent LLL between the groups of 0.08 mm was 0.15 and therefore within the pre-specified non-inferiority margin of 0.17 mm (p for non-inferiority = 0.013). However, the test for superiority showed a borderline significant difference in terms of LLL between DP-EES and DP-SES (p for superiority = 0.044). There were no significant differences in binary restenosis (2.0% vs. 0.72%, p = 0.44) and percent diameter stenosis (14.97±12.17 vs. 13.36±10.82, p = 0.19). The rate of definite stent thrombosis at 12 months was lower in patients treated with DP-EES (0% vs. 2.0%, p = 0.036). CONCLUSIONS: Among women undergoing PCI, DP-EES was associated with a small but probably clinically relevant increase in in-stent LLL at 9 months as compared to DP-SES and with a lower risk of definite stent thrombosis at 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT01182428. https://clinicaltrials.gov/.

15 Article Bioresorbable scaffolds: in search of event-free dissolution. 2017

Piccolo, Raffaele / Jüni, Peter / Windecker, Stephan. ·Department of Cardiology, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. · Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada. · Department of Cardiology, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Lancet · Pubmed #28732814.

ABSTRACT: -- No abstract --

16 Article Effects of coronary artery disease in patients undergoing transcatheter aortic valve implantation: A study of age- and gender-matched cohorts. 2017

Franzone, Anna / Stortecky, Stefan / Räber, Lorenz / Heg, Dik / Yamaji, Kyohei / Piccolo, Raffaele / Asami, Masahiko / Lanz, Jonas / Praz, Fabien / Koskinas, Kostantinos / Zanchin, Thomas / Wenaweser, Peter / Valgimigli, Marco / Jüni, Peter / Pilgrim, Thomas / Windecker, Stephan. ·Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. · Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Canada; Department of Medicine, University of Toronto, Canada. · Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Int J Cardiol · Pubmed #28536005.

ABSTRACT: BACKGROUND: The prognostic role of concomitant coronary artery disease (CAD) among patients undergoing transcatheter aortic valve implantation (TAVI) is still uncertain. METHODS: Data from the Bern TAVI Registry and the Bern PCI Registry were analyzed. Patients with concomitant CAD undergoing TAVI (TAVI+CAD) were age- and gender-matched to the following two cohorts: patients without CAD undergoing TAVI (TAVI-noCAD) and patients with stable CAD undergoing percutaneous coronary intervention (CAD-noAS). Major adverse cardiovascular and cerebrovascular events (MACCE), defined as the composite of cardiovascular death, myocardial infarction, or cerebrovascular events, represented the primary endpoint at 1-year. RESULTS: Out of 9478 procedures performed between 2007 and 2013 (807 TAVI; 8671 PCI), three cohorts, each including 248 subjects, were derived. At 1-year, MACCE were significantly increased among TAVI+CAD compared with TAVI-noCAD (16.8% vs. 9.8%, hazard ratio, HR, 1.75, 95% confidence intervals, CI, 1.06-2.89, p=0.030) and CAD-noAS patients (16.8% vs. 9.5%, HR 1.85, 95%CI 1.11-3.09, p=0.018) whereas no difference was found between TAVI-noCAD and CAD-noAS patients. The higher rate of MACCE among TAVI+CAD patients was mainly driven by an increased risk of cardiovascular mortality compared with the TAVI-noCAD (HR 1.86, 95%CI 1.03-3.36, p=0.040) and CAD-noAS cohorts (HR 2.29, 95%CI 1.22-4.30, p=0.010). The 1-year rate of MACCE was similar between TAVI-noCAD and CAD-noAS patients (9.8% vs. 9.5%, HR 1.05, 95%CI 0.59-1.87, p=0.86). CONCLUSIONS: Concomitant CAD in the setting of TAVI conveyed an increased risk of ischemic events and cardiovascular mortality at 1-year follow-up.

17 Article Impact of Patient and Lesion Complexity on Long-Term Outcomes Following Coronary Revascularization With New-Generation Drug-Eluting Stents. 2017

Koskinas, Konstantinos C / Taniwaki, Masanori / Rigamonti, Fabio / Heg, Dik / Roffi, Marco / Tüller, David / Muller, Olivier / Vuillomenet, Andre / Cook, Stephane / Weilenmann, Daniel / Kaiser, Christopher / Jamshidi, Peiman / Jüni, Peter / Windecker, Stephan / Pilgrim, Thomas. ·Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. · Department of Cardiology, University Hospital, Geneva, Switzerland. · Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland. · Department of Cardiology, Triemlispital, Zurich, Switzerland. · Department of Cardiology, University Hospital, Lausanne, Switzerland. · Department of Cardiology, Kantonsspital, Aarau, Switzerland. · Department of Cardiology, University Hospital, Fribourg, Switzerland. · Department of Cardiology, Kantonsspital, St. Gallen, Switzerland. · Department of Cardiology, University Hospital, Basel, Switzerland. · Department of Cardiology, Kantonsspital, Luzern, Switzerland. · Applied Health Research Centre (AHRC), St. Michael's Hospital, Toronto, Ontario, Canada. · Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. Electronic address: stephan.windecker@insel.ch. ·Am J Cardiol · Pubmed #27923461.

ABSTRACT: Long-term clinical outcomes of new-generation drug-eluting stents in complex anatomic and clinical settings are not well defined. This study assessed the impact of patient and lesion complexity on 2-year outcomes after coronary revascularization with ultrathin strut biodegradable-polymer (BP) sirolimus-eluting stents (SES) versus durable-polymer (DP) everolimus-eluting stents (EES). In a prespecified analysis of the BIOSCIENCE randomized trial (NCT01443104), complex patients (911 of 2,119; 43%) were defined by the presence of acute ST-elevation myocardial infarction (MI); left ventricular ejection fraction ≤30%; renal dysfunction; insulin-treated diabetes; treatment of ostial lesion, bypass graft, unprotected left main lesion; or 3-vessel intervention. The primary end point was target lesion failure (TLF), a composite of cardiac death, target vessel MI, and clinically indicated target lesion revascularization. At 2 years, complex compared with simple patients had a greater risk of TLF (14.5% vs 7.4%, risk ratio 2.05, 95% confidence interval 1.56 to 2.69; p <0.001). The difference was sustained beyond 1 year on landmark analysis. Complex patients had higher rates of the patient-oriented composite end point of death, any MI, or any revascularization (23% vs 14.4%; p <0.001) as well as definite stent thrombosis (1.6% vs 0.4%, p = 0.006). There were no differences in TLF and patient-oriented composite end point between the BP-SES versus DP-EES, consistently among simple and complex patients. In conclusion, patient and lesion complexity had a durable adverse impact on clinical outcomes throughout 2 years of follow-up in this all-comers randomized trial. Safety and efficacy of new-generation BP-SES and DP-EES were comparable, irrespective of complexity status.

18 Article A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. 2016

Barbato, Emanuele / Toth, Gabor G / Johnson, Nils P / Pijls, Nico H J / Fearon, William F / Tonino, Pim A L / Curzen, Nick / Piroth, Zsolt / Rioufol, Gilles / Jüni, Peter / De Bruyne, Bernard. ·Cardiovascular Research Center Aalst OLV Hospital, Aalst, Belgium; Department of Advanced Biomedical Science, University of Naples Federico II, Naples, Italy. Electronic address: emanuele.barbato@olvz-aalst.be. · Department of Cardiology, University Heart Center Graz, Graz, Austria. · Division of Cardiology, Department of Medicine, University of Texas Medical School, Houston, Texas. · Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands. · Stanford University Medical Center, Stanford, California. · Department of Cardiology, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom. · Gottsegen Gyorgy Hungarian Institute of Cardiology, Budapest, Hungary. · Interventional Cardiology Department, Hospices Civils de Lyon, Claude Bernard University Lyon 1 and CARMEN INSERM, Bron, France. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada; Department of Medicine, University of Toronto, Toronto, Canada. · Cardiovascular Research Center Aalst OLV Hospital, Aalst, Belgium. ·J Am Coll Cardiol · Pubmed #27884241.

ABSTRACT: BACKGROUND: In patients with coronary artery disease, clinical outcome depends on the extent of reversible myocardial ischemia. Whether the outcome also depends on the severity of the stenosis as determined by fractional flow reserve (FFR) remains unknown. OBJECTIVES: This study sought to investigate the relationship between FFR values and vessel-related clinical outcome. METHODS: We prospectively studied major adverse cardiovascular events (MACE) at 2 years in 607 patients in whom all stenoses were assessed by FFR and who were treated with medical therapy alone. The relationship between FFR and 2-year MACE was assessed as a continuous function. Logistic and Cox proportional hazards regression models were used to calculate the average decrease in the risk of MACE per 0.05-U increase in FFR. RESULTS: MACE occurred in 272 (26.5%) of 1,029 lesions. Target lesions with diameter stenosis ≥70% were more often present in the MACE group (p < 0.01). Median FFR was significantly lower in the MACE group versus the non-MACE group (0.68 [interquartile range: 0.54 to 0.77] vs. 0.80 [interquartile range: 0.70 to 0.88]; p < 0.01). The cumulative incidence of MACE significantly increased with increasing FFR quartiles. An average decrease in MACE per 0.05-unit increase in FFR was statistically significant even after adjustment for all clinical and angiographic features (odds ratio: 0.81; 95% confidence interval: 0.76 to 0.86]). The strongest increase in MACE occurred for FFR values between 0.80 and 0.60. In multivariable Cox regression analysis, FFR was significantly associated with MACE up to 2 years (hazard ratio: 0.87; 95% confidence interval: 0.83 to 0.91]). CONCLUSIONS: In patients with stable coronary disease, stenosis severity as assessed by FFR is a major and independent predictor of lesion-related outcome. (FAME II - Fractional Flow Reserve [FFR] Guided Percutaneous Coronary Intervention [PCI] Plus Optimal Medical Treatment [OMT] Verses OMT; NCT01132495).

19 Article Angiographic complexity of coronary artery disease according to SYNTAX score and clinical outcomes after revascularisation with newer-generation drug-eluting stents: a substudy of the BIOSCIENCE trial. 2016

Franzone, Anna / Taniwaki, Masanori / Rigamonti, Fabio / Heg, Dik / Piccolo, Raffaele / Roffi, Marco / Tüller, David / Muller, Olivier / Vuilliomenet, Andre / Cook, Stéphane / Weilenmann, Daniel / Kaiser, Christoph / Jamshidi, Peiman / Jüni, Peter / Windecker, Stephan / Pilgrim, Thomas. ·Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. ·EuroIntervention · Pubmed #27497359.

ABSTRACT: AIMS: We sought to assess the performance of drug-eluting stents combining an ultrathin cobalt-chromium platform with a biodegradable polymer across categories of increasing SYNTAX score (SS). METHODS AND RESULTS: Patients included in the BIOSCIENCE trial and randomly allocated to treatment with biodegradable polymer sirolimus-eluting stents (BP-SES) or durable polymer everolimus-eluting stents (DP-EES) were categorised according to SS tertiles (low <8, medium 8-15, high >15). The primary endpoint, target lesion failure (TLF), was defined as a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation. The patient-oriented endpoint (POCE) included death, myocardial infarction, or any repeat revascularisation. The SS was available in 2,041 out of 2,119 patients (96.3%). At two-year follow-up, patients with an SS >15 experienced higher rates of both TLF and POCE as compared to patients with medium and low SS (14.5% vs. 8.1% and vs. 5.9%, p<0.001; 22.7% vs. 14.9% and vs. 12.4%; p<0.001), respectively. Comparable rates of the composite endpoints were documented for both stent types in each category of SS. CONCLUSIONS: Increasing lesion complexity as assessed by SS was associated with higher rates of TLF and POCE in a contemporary PCI population with minimal exclusion criteria. BP-SES and DP-EES showed comparable performance across the entire spectrum of CAD severity.

20 Article Duration of Triple Antithrombotic Therapy and Outcomes Among Patients Undergoing Percutaneous Coronary Intervention. 2016

Koskinas, Konstantinos C / Räber, Lorenz / Zanchin, Thomas / Pilgrim, Thomas / Stortecky, Stefan / Hunziker, Lukas / Blöchlinger, Stefan / Billinger, Michael / Gartwyl, Fabienne / Moro, Christina / Moschovitis, Aris / Jüni, Peter / Heg, Dik / Windecker, Stephan. ·Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: lorenz.raeber@insel.ch. · Department of Medicine, University of Toronto, Toronto, Canada. · Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. ·JACC Cardiovasc Interv · Pubmed #27478115.

ABSTRACT: OBJECTIVES: The aim of this study was to compare clinical outcomes in relation to the duration of triple antithrombotic therapy (TAT) among patients with indications for oral anticoagulation undergoing percutaneous coronary intervention (PCI). BACKGROUND: TAT is recommended for patients undergoing PCI with a firm indication for oral anticoagulation. Duration of TAT may influence outcomes, but the optimal period of TAT remains uncertain. METHODS: Between 2009 and 2013, 8,772 consecutive patients undergoing PCI for stable coronary artery disease or acute coronary syndrome were prospectively included in the Bern PCI Registry (NCT02241291). Of 568 patients with indications for oral anticoagulation, 245 (43%) were discharged on a regimen of 1-month TAT and 323 (57%) on a regimen >1-month TAT (mean 5.1 ± 3.3 months, median 3 months). The primary endpoint was a composite of cardiac death, myocardial infarction, stroke, definite stent thrombosis, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding within 1 year. RESULTS: Patients on 1-month compared with >1-month TAT were more commonly women, with stable coronary artery disease, had higher HAS-BLED scores, and less frequently received drug-eluting stents. In multivariate analyses, the primary endpoint did not differ between groups (adjusted hazard ratio: 1.07; 95% confidence interval: 0.56 to 2.06; p = 0.84). Results were consistent in stratified analyses in relation to clinical presentation with acute coronary syndrome (38%) and PCI with drug-eluting stents (79%) (p for interaction = 0.18 and 0.95, respectively). There were no differences in the secondary bleeding endpoint, Bleeding Academic Research Consortium ≥3 bleeding (adjusted hazard ratio: 0.62; 95% confidence interval: 0.21 to 1.80; p = 0.37) and the secondary composite ischemic endpoint (cardiac death, myocardial infarction, stroke, or definite stent thrombosis) (adjusted hazard ratio: 1.12; 95% confidence interval: 0.55 to 2.29; p = 0.76). CONCLUSIONS: One-month TAT, used preferentially in patients with higher estimated bleeding risk in this observational study, was associated with similar net clinical outcomes compared with longer TAT durations throughout 1 year following PCI.

21 Article Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. 2016

Ferrante, Giuseppe / Rao, Sunil V / Jüni, Peter / Da Costa, Bruno R / Reimers, Bernhard / Condorelli, Gianluigi / Anzuini, Angelo / Jolly, Sanjit S / Bertrand, Olivier F / Krucoff, Mitchell W / Windecker, Stephan / Valgimigli, Marco. ·Department of Cardiovascular Medicine, Humanitas Research Hospital, Humanitas Clinical and Research Center, Rozzano, Italy. Electronic address: giu.ferrante@hotmail.it. · Duke Clinical Research Institute, Durham, North Carolina. · Applied Health Research Centre The HUB, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Department of Medicine, University of Toronto, Toronto, Ontario, Canada. · Institute of Primary Health Care, University of Bern, Bern, Switzerland. · Department of Cardiovascular Medicine, Humanitas Research Hospital, Humanitas Clinical and Research Center, Rozzano, Italy. · Department of Cardiovascular Medicine, Humanitas Research Hospital, Humanitas Clinical and Research Center, Rozzano, Italy; Humanitas University, Rozzano, Italy. · Department of Interventional Cardiology, Humanitas Mater Domini, Castellanza, Italy. · McMaster University and Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. · Interventional Cardiology, Quebec Heart-Lung Institute, Quebec City, Quebec, Canada. · Department of Cardiology, Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Department of Cardiology, Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. Electronic address: marco.valgimigli@insel.ch. ·JACC Cardiovasc Interv · Pubmed #27372195.

ABSTRACT: OBJECTIVES: The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD). BACKGROUND: Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD. METHODS: The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed. RESULTS: Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p = 0.001, number needed to treat to benefit [NNTB] = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints. CONCLUSIONS: Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD.

22 Article Preprocedural High-Sensitivity Cardiac Troponin T and Clinical Outcomes in Patients With Stable Coronary Artery Disease Undergoing Elective Percutaneous Coronary Intervention. 2016

Zanchin, Thomas / Räber, Lorenz / Koskinas, Konstantinos C / Piccolo, Raffaele / Jüni, Peter / Pilgrim, Thomas / Stortecky, Stefan / Khattab, Ahmed A / Wenaweser, Peter / Bloechlinger, Stefan / Moschovitis, Aris / Frenk, Andre / Moro, Christina / Meier, Bernhard / Fiedler, Georg M / Heg, Dik / Windecker, Stephan. ·From the Department of Cardiology, Bern University Hospital, Switzerland (T.Z., L.R., K.C.K., R.P., T.P., S.S., A.A.K., P.W., S.B., A.M., A.F., C.M., B.M., S.W.) · Applied Health Research Centre, St Michael's Hospital, University of Toronto, Canada (P.J.) · Center for Laboratory Medicine, Inselspital, University Hospital Bern, Switzerland (G.M.F.) · and Institute of Social and Preventive Medicine, University of Bern, Switzerland (D.H.). ·Circ Cardiovasc Interv · Pubmed #27296200.

ABSTRACT: BACKGROUND: Cardiac troponin detected by new-generation, highly sensitive assays predicts clinical outcomes among patients with stable coronary artery disease (SCAD) treated medically. The prognostic value of baseline high-sensitivity cardiac troponin T (hs-cTnT) elevation in SCAD patients undergoing elective percutaneous coronary interventions is not well established. This study assessed the association of preprocedural levels of hs-cTnT with 1-year clinical outcomes among SCAD patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: Between 2010 and 2014, 6974 consecutive patients were prospectively enrolled in the Bern Percutaneous Coronary Interventions Registry. Among patients with SCAD (n=2029), 527 (26%) had elevated preprocedural hs-cTnT above the upper reference limit of 14 ng/L. The primary end point, mortality within 1 year, occurred in 20 patients (1.4%) with normal hs-cTnT versus 39 patients (7.7%) with elevated baseline hs-cTnT (P<0.001). Patients with elevated hs-cTnT had increased risks of all-cause (hazard ratio 5.73; 95% confidence intervals 3.34-9.83; P<0.001) and cardiac mortality (hazard ratio 4.68; 95% confidence interval 2.12-10.31; P<0.001). Preprocedural hs-TnT elevation remained an independent predictor of 1-year mortality after adjustment for relevant risk factors, including age, sex, and renal failure (adjusted hazard ratio 2.08; 95% confidence interval 1.10-3.92; P=0.024). A graded mortality risk was observed across higher tertiles of elevated preprocedural hs-cTnT, but not among patients with hs-cTnT below the upper reference limit. CONCLUSIONS: Preprocedural elevation of hs-cTnT is observed in one fourth of SCAD patients undergoing elective percutaneous coronary intervention. Increased levels of preprocedural hs-cTnT are proportionally related to the risk of death and emerged as independent predictors of all-cause mortality within 1 year. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02241291.

23 Article Plasma ceramides predict cardiovascular death in patients with stable coronary artery disease and acute coronary syndromes beyond LDL-cholesterol. 2016

Laaksonen, Reijo / Ekroos, Kim / Sysi-Aho, Marko / Hilvo, Mika / Vihervaara, Terhi / Kauhanen, Dimple / Suoniemi, Matti / Hurme, Reini / März, Winfried / Scharnagl, Hubert / Stojakovic, Tatjana / Vlachopoulou, Efthymia / Lokki, Marja-Liisa / Nieminen, Markku S / Klingenberg, Roland / Matter, Christian M / Hornemann, Thorsten / Jüni, Peter / Rodondi, Nicolas / Räber, Lorenz / Windecker, Stephan / Gencer, Baris / Pedersen, Eva Ringdal / Tell, Grethe S / Nygård, Ottar / Mach, Francois / Sinisalo, Juha / Lüscher, Thomas F. ·Zora Biosciences, Espoo, Finland Medical School, Tampere University, Tampere, Finland Finnish Clinical Biobank Tampere, University Hospital of Tampere, Tampere, Finland reijo.laaksonen@zora.fi. · Zora Biosciences, Espoo, Finland. · Medical Clinic V (Nephrology, Hypertensiology, Rheumatology, Endocrinology, Diabetology), Medical Faculty Mannheim, University of Heidelberg, Heidelberg, Germany synlab Academy, synlab Holding Deutschland GmbH, Mannheim and Augsburg, Germany. · Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University Graz, Graz, Austria. · Transplantation Laboratory, Haartman Institute, University of Helsinki, Helsinki, Finland. · Transplantation Laboratory, Haartman Institute, University of Helsinki, Helsinki, Finland Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland. · Department of Cardiology, University Heart Center, University Hospital Zürich and University of Zürich, Zürich, Switzerland. · Institute of Clinical Chemistry, University Hospital, Zürich, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, and Department of Medicine, University of Toronto, Toronto, Canada. · Department of General Internal Medicine, University Hospital Bern, Bern, Switzerland Department of Ambulatory Care and Community Medicine, University of Lausanne, Lausanne, Switzerland. · Cardiovascular Center, Department of Cardiology, University Hospital Bern, Bern, Switzerland. · Cardiovascular Center, Department of Cardiology, University Hospital Geneva, Geneva, Switzerland. · Department of Clinical Science, University of Bergen, Bergen, Norway. · Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway. · Department of Clinical Science, University of Bergen, Bergen, Norway Department of Heart Disease, Haukeland University Hospital, Bergen, Norway. ·Eur Heart J · Pubmed #27125947.

ABSTRACT: AIMS: The aim was to study the prognostic value of plasma ceramides (Cer) as cardiovascular death (CV death) markers in three independent coronary artery disease (CAD) cohorts. METHODS AND RESULTS: Corogene study is a prospective Finnish cohort including stable CAD patients (n = 160). Multiple lipid biomarkers and C-reactive protein were measured in addition to plasma Cer(d18:1/16:0), Cer(d18:1/18:0), Cer(d18:1/24:0), and Cer(d18:1/24:1). Subsequently, the association between high-risk ceramides and CV mortality was investigated in the prospective Special Program University Medicine-Inflammation in Acute Coronary Syndromes (SPUM-ACS) cohort (n = 1637), conducted in four Swiss university hospitals. Finally, the results were validated in Bergen Coronary Angiography Cohort (BECAC), a prospective Norwegian cohort study of stable CAD patients. Ceramides, especially when used in ratios, were significantly associated with CV death in all studies, independent of other lipid markers and C-reactive protein. Adjusted odds ratios per standard deviation for the Cer(d18:1/16:0)/Cer(d18:1/24:0) ratio were 4.49 (95% CI, 2.24-8.98), 1.64 (1.29-2.08), and 1.77 (1.41-2.23) in the Corogene, SPUM-ACS, and BECAC studies, respectively. The Cer(d18:1/16:0)/Cer(d18:1/24:0) ratio improved the predictive value of the GRACE score (net reclassification improvement, NRI = 0.17 and ΔAUC = 0.09) in ACS and the predictive value of the Marschner score in stable CAD (NRI = 0.15 and ΔAUC = 0.02). CONCLUSIONS: Distinct plasma ceramide ratios are significant predictors of CV death both in patients with stable CAD and ACS, over and above currently used lipid markers. This may improve the identification of high-risk patients in need of more aggressive therapeutic interventions.

24 Article External validity of the "all-comers" design: insights from the BIOSCIENCE trial. 2016

Franzone, Anna / Heg, Dik / Räber, Lorenz / Valgimigli, Marco / Piccolo, Raffaele / Zanchin, Thomas / Yamaji, Kyohei / Stortecky, Stefan / Blöchlinger, Stefan / Hunziker, Lukas / Praz, Fabien / Jüni, Peter / Windecker, Stephan / Pilgrim, Thomas. ·Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, 3010, Bern, Switzerland. · Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland. · Clinical Trials Unit, Department of Clinical Research, University of Bern, Bern, Switzerland. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada. · Department of Medicine, University of Toronto, Toronto, Canada. · Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, 3010, Bern, Switzerland. stephan.windecker@insel.ch. ·Clin Res Cardiol · Pubmed #27033859.

ABSTRACT: OBJECTIVES: We sought to systematically evaluate the external validity of a contemporary randomized controlled stent trial (BIOSCIENCE). METHODS: Baseline characteristics and clinical outcomes of patients enrolled into the BIOSCIENCE trial at Bern University Hospital (n = 1216) were compared to those of patients included in the CARDIOBASE Bern PCI Registry at the same institution (n = 1045). The primary study endpoint was the rate of target lesion failure (TLF), defined as a composite of cardiac death, target vessel-myocardial infarction (MI) or target lesion revascularization (TLR), at 1 year. RESULTS: Women were underrepresented in the RCT compared to the registry (25 vs. 29.4 %, p = 0.020). Non-participants were older compared to study participants (69.2 ± 12.4 vs. 67.0 ± 11.6, p < 0.001), and had a higher prevalence of previous cerebrovascular events (10.8 vs. 5.2 %, p < 0.001), and chronic renal failure (35.5 vs. 15.6 %, p < 0.001). ST-segment elevation myocardial infarction (STEMI) and Killip class IV at presentation were more common among non-participants than participants (30.7 vs. 21.1 %, p < 0.001 and 7.8 vs. 0.4 %, p < 0.001, respectively). At 1 year, non-participants experienced a significantly higher rate of TLF, (15.0 vs. 6.5 %, p < 0.001), and patient-oriented composite endpoint (POCE), including death, MI or any repeat revascularization (21.6 vs. 11.2 %, p < 0.001). There was a significant interaction between POCE and presence or absence of an acute coronary syndrome in participants versus non-participants, respectively (p = 0.009). CONCLUSIONS: Non-participants of this all-comers trial had a higher risk profile and adverse prognosis compared to study participants. Further efforts are needed to improve the external validity of contemporary RCTs.

25 Article Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable-Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularization: 2-Year Results of the BIOSCIENCE Trial. 2016

Zbinden, Rainer / Piccolo, Raffaele / Heg, Dik / Roffi, Marco / Kurz, David J / Muller, Olivier / Vuilliomenet, André / Cook, Stéphane / Weilenmann, Daniel / Kaiser, Christoph / Jamshidi, Peiman / Franzone, Anna / Eberli, Franz / Jüni, Peter / Windecker, Stephan / Pilgrim, Thomas. ·Department of Cardiology, Triemlispital, Zurich, Switzerland. · Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland. · Institute of Social and Preventive Medicine and Clinical Trials Unit, Bern University Hospital, Bern, Switzerland. · Department of Cardiology, University Hospital, Geneva, Switzerland. · Department of Cardiology, University Hospital, Lausanne, Switzerland. · Department of Cardiology, Kantonsspital, Aarau, Switzerland. · Department of Cardiology, University Hospital, Fribourg. · Department of Cardiology, Kantonsspital, St. Gallen, Switzerland. · Department of Cardiology, University Hospital, Basel, Switzerland. · Department of Cardiology, Kantonsspital, Luzern, Switzerland. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·J Am Heart Assoc · Pubmed #26979080.

ABSTRACT: BACKGROUND: No data are available on the long-term performance of ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES). We reported 2-year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP-SES with durable-polymer everolimus-eluting stents (DP-EES) in patients undergoing percutaneous coronary intervention. METHODS AND RESULTS: A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP-SES (n=1063) or DP-EES (n=1056). Follow-up at 2 years was available for 2048 patients (97%). The primary end point was target-lesion failure, a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. At 2 years, target-lesion failure occurred in 107 patients (10.5%) in the BP-SES arm and 107 patients (10.4%) in the DP-EES arm (risk ratio [RR] 1.00, 95% CI 0.77-1.31, P=0.979). There were no significant differences between BP-SES and DP-EES with respect to cardiac death (RR 1.01, 95% CI 0.62-1.63, P=0.984), target-vessel myocardial infarction (RR 0.91, 95% CI 0.60-1.39, P=0.669), target-lesion revascularization (RR 1.17, 95% CI 0.81-1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56-3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP-SES arm and 4 cases (0.4%) in the DP-EES arm (P=0.423). In the prespecified subgroup of patients with ST-segment elevation myocardial infarction, BP-SES was associated with a lower risk of target-lesion failure compared with DP-EES (RR 0.48, 95% CI 0.23-0.99, P=0.043, Pinteraction=0.026). CONCLUSIONS: Comparable safety and efficacy profiles of BP-SES and DP-EES were maintained throughout 2 years of follow-up. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.

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